JP2019523397A - Modular assay reader device - Google Patents

Abstract

Some aspects relate to a system and method of use for a modular lateral flow assay reader device that can accommodate a plurality of different modules having a barcode scanning input device and optional network connectivity. The bar code scanning module can provide a simple input method that reduces errors compared to manual data entry. A network connectivity module may allow the transmission of test results over a public network to standardize, track and electronically connect test results from assay reader devices scattered within the network . Such a device is prepared by pressing a single button so that the device is ready for imaging, analysis and data storage / transmission, and in some implementations, operates in one of multiple modes of operation of the device. A simple workflow can be implemented programmatically. [Selection] Figure 1A

Description

[Cross-reference with related applications]
This application is filed on Sep. 12, 2016, US Provisional Patent Application No. 62 / 393,575 entitled “MODULAR ASSAY READER DEVICE” and on Jun. 22, 2016. It claims the benefit of US Provisional Patent Application No. 62 / 353,505, entitled “Modular Assay Reader Device”, the contents of which are incorporated herein by reference.

  The systems and methods disclosed herein relate to medical testing, and specifically to lateral flow assays and devices.

  In patient therapy, immunoassay techniques provide a simple and relatively quick means for confirming the presence of an analyte in a subject sample. An analyte is an important or clinically significant substance that can be present in biological or non-biological fluids. The specimen can include antibodies, antigens, drugs or hormones.

  The analyte of interest is generally detected by reaction with a capture agent that makes detection and measurement by the device easier than the original analyte. The detection method can be measured easily as absorbance change, color change, fluorescence change, brightness change, surface potential change, other optical property change, or any other indication of the presence or absence of analyte in the sample. Physical properties can be included.

  Immunoassay devices play an important role in fields such as clinical chemistry and are made portable for use in the field. Assays are routinely performed to detect the presence of a particular analyte that is present when a human or non-human subject has a particular disease or condition. For example, the assays described herein may include ovulation or pregnancy status, whether the patient is infected with influenza A, influenza B, RSV, group A streptococcus or another disease, to name just a few. It can be used to detect whether there is a certain drug or compound in the body.

  Such assays and assay reader devices are used by skilled clinicians and similar non-specialists. Thus, an assay reader device according to the present disclosure needs to be performed, for example, by including a module for simply entering any necessary additional information with barcode scanning, as well as between the application of the sample and notification of the result. It is designed to be simple and reliable by minimizing a certain number of steps. Barcode scanning input can enable a high level of traceability and compliance by allowing the implementation of unique test result documentation standards, such as by hospitals and laboratories. Some examples can enhance compliance with such criteria at the reader level, for example by configuring the reader in advance to require entry of a specified information type before sending the results. As another example, the communication between the reader and the centralized database is used to check whether the transmitted examination data conforms to such criteria, and if it does not conform to the user, any unknown information Can be sent back to the reader device. Further, such assays and assay reader devices can be used in a variety of situations within and outside the clinical environment. Accordingly, an assay reader device according to the present disclosure can include a module that provides network connectivity capabilities to provide test results to one or more centralized databases.

  Accordingly, one aspect is a diagnostic test apparatus that is arranged to detect a change in an optical property of an assay after applying a biological sample to the assay and that indicates a change in the optical property of the detected assay An optical sensor configured to generate a bay, a bay configured to receive and engage a connection module of a plurality of replaceable modules, and a bar code scanner in the connection module A first signal path configured to identify a connection module characteristic indicative of the connection module and a connection capability of the connection module, and configured to receive barcode data representing the barcode imaged by the connection module from the connection module. A module interface including a second signal path, at least one processor, and storing instructions And wherein the instructions determine at least one processor a test result based at least in part on the signal generated by the optical sensor, identify the barcode as an identification information barcode, In response to determining that the connection information of the connection module is determined based on the identification information based on the identification information, and determining that the connection module has the connection capability with the remote storage device, Automatically transmit to the storage device, and in response to determining that the connection module does not have the connection capability with the remote storage device, the test result is automatically stored in the memory in association with the identification information It is related with the diagnostic test | inspection apparatus which comprises.

  Some embodiments can further include an additional optical sensor arranged to detect additional information on the assay or on the cartridge holding the assay, at least one processor using the additional information to diagnose It is configured to define operating parameters of the inspection device. Some embodiments may further include an additional optical sensor arranged to detect additional information on the assay or on a cartridge holding the assay, wherein at least one processor may include this additional information as a test result. It is configured to store in association.

  Some embodiments may further include a connection module. The connection module can include a barcode scanner. The connectivity module can include a cellular modem configured to provide connectivity capabilities. The connection module can include an information element, and the at least one processor is configured to retrieve the module information from the information element via the first signal path and determine the connection capability of the connection module based on the module information. Is done.

  Another aspect is a non-transitory computer-readable medium configured to have computer-executable instructions that are inserted into a hardware processor at run time into a bay of an assay reader device. Identifying the characteristics of the connection module indicative of the presence of the barcode scanner in the connection module and the connection capability of the connection module; and from the assay reading image sensor of the assay reader apparatus, or inserted into the assay reader apparatus or the assay reader apparatus Receiving assay image data representing changes in detected optical properties of an assay located adjacent to the device, determining test results based at least in part on analysis of the assay image data, and identified properties Determining the connection capacity of the connection module based on Automatically transmitting test results to the remote storage device in response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device; Relates to a non-transitory computer-readable medium that causes a test result to be automatically stored in a memory of an assay reader device in response to determining that the device does not have a connection capability with a remote storage device.

  The non-transitory computer readable medium, at runtime, receives at least one barcode based on the analysis of the barcode image data and the hardware processor receiving barcode image data representing at least one barcode from the connection module. An instruction can be further stored that causes the instruction to be identified as an instruction barcode and to retrieve an instruction associated with the instruction barcode. The non-transitory computer readable medium may further store instructions that, when executed, cause the hardware processor to determine a test result based at least in part on the instructions. The non-transitory computer readable medium reads the assay read data at runtime at a predetermined time after inserting the assay into the assay reader device, based at least in part on the instructions, to a hardware processor. Instructions for causing the image sensor to instruct can further be stored.

  The non-transitory computer readable medium, at runtime, receives at least one barcode based on the analysis of the barcode image data and the hardware processor receiving barcode image data representing at least one barcode from the connection module. Determined to identify as an identification barcode, determine the information represented by the identification barcode, and determine that the connection module has the ability to connect to a remote storage device physically separated from the assay reader device In response, the information represented by the identification bar code is automatically transmitted to the remote storage device together with the inspection result, and the connection module is determined not to have the connection capability with the remote storage device. In response, the information represented by the identification barcode is displayed along with the test results in the memo of the assay reader device. It may further store instructions to perform the method comprising: automatically stored in.

  Another aspect is a diagnostic test method, in which one or more hardware processors are inserted into a bay of an assay reader device, the presence of a barcode scanner in the connection module, and the connection capability of the connection module An assay representative of a change in detected optical properties of the assay inserted into or adjacent to the assay reader device from the assay read image sensor of the assay reader device Receiving the image data; determining a test result based at least in part on an analysis of the assay image data; determining a connection capability of the connection module based on the identified characteristics; Connection to a remote storage device physically separated from the device In response to determining that the connection module has the power, automatically transmitting the test result to the remote storage device, and determining that the connection module does not have the connection capability with the remote storage device. And in response, automatically storing test results in the memory of the assay reader device.

  The method includes receiving barcode image data representing at least one barcode from a connection module, identifying at least one barcode as an instruction barcode based on analysis of the barcode image data, and an instruction barcode Searching for instructions related to. The method can further include determining a test result based at least in part on the instructions. The method can further include instructing the assay read image sensor to acquire assay image data at a predetermined timing after inserting the assay into the assay reader device based at least in part on the instructions.

  The method includes receiving barcode image data representing at least one barcode from the connection module; identifying at least one barcode as an identification barcode based on analysis of the barcode image data; and by the identification barcode Determining the information to be represented. In response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device, the method remotely stores the information represented by the identification barcode along with the test results. In response to determining that the connection module does not have a connection capability with the remote storage device and transmitting the information represented by the identification barcode together with the test result to the assay reader device. Automatically storing in memory. The method was identified based on the information represented by the identification barcode in response to determining that the connection module has the ability to connect to a remote storage device that is physically separate from the assay reader device. The method may further include automatically transmitting a command to transfer the test result from the remote storage device to another remote storage device. The method was identified based on the information represented by the identification barcode in response to determining that the connection module has the ability to connect to a remote storage device that is physically separate from the assay reader device. The method may further include automatically transmitting the test result to the clinician's personal computer device.

  DETAILED DESCRIPTION Aspects of the present disclosure are described below with reference to the accompanying drawings, which are provided by way of illustration and not limitation, wherein like elements are designated with like symbols.

It is a figure which shows a series of example of a component of an assay reader system. It is a figure which shows the assembly example of the reader and module of the assay reader system of FIG. 1A. 1 is a schematic block diagram of an example data network including an assay reader system of the present disclosure. FIG. It is a schematic block diagram of an example of an assay reader device. It is a flowchart which shows the example of an operation | movement method of the assay reader apparatus disclosed by this specification. It is a figure which shows the example of a hospital workflow which does not use the solution of a wireless point of care test | inspection. FIG. 6 illustrates an example hospital workflow that implements a streamlined workflow through an assay reader device of the present disclosure that provides a wireless point-of-care test solution. It is a figure which shows the example of the various display text which can be shown to an operator on the display screen of the assay reader apparatus demonstrated in this specification.

Introduction Embodiments of the present disclosure relate to systems and methods for modular assay reader devices that can accommodate a plurality of different modules having a barcode scanning input device and optional network connectivity. Embodiments of the reader device may be portable, for example, relatively small and light and optionally operating with stored power. The reader device of the present disclosure may be used in hospitals, clinics, medical offices and other patient treatment facilities to allow for rapid detection and identification of many types of biological conditions such as the presence of infectious antibodies. it can. A network connectivity module can standardize, track and electronically connect test results from reader devices interspersed within the network to improve patient care.

  One type of reader device is configured to read or otherwise analyze lateral flow assays that can examine various medical and environmental conditions or compounds. For example, lateral flow testing can rely on a form of immunoassay in which the test sample flows along the solid substrate through capillary action. The lateral flow assay reader device can read the lateral flow assay strip to detect the presence of an antigen derived from a hormone, metabolite, toxin, or pathogen. This reading is based on the presence or absence of visible lines on lateral flow assays such as, but not limited to, PIN detectors, linear array detectors, CMOS imagers and CCD-based imagers. Can be performed using a detector that includes one or more sensing elements configured to detect the presence or absence. Some tests performed by assay reader devices are designed to make quantitative decisions, but these tests return or indicate a positive / negative qualitative indicator in many situations. Designed. Examples of assays that allow such qualitative analysis include blood typing, most types of urine testing, pregnancy testing and HIV / AIDS testing. The assay reader device can identify the results of such a test by autonomously following a preprogrammed decision making process or decision making rules. In addition to reader devices configured to analyze lateral flow assays, the implementation of the diagnostic reader device described herein can analyze other types of assays, such as but not limited to molecular assays. Diagnostic test results can also be provided.

  The assay reader device can be a one-stage device that only requires the sample to be applied before the user observes the results and optionally before sending the results to the appropriate hospital, laboratory, or medical records database. . Such single stage devices can eliminate the need to perform complex and time consuming processing steps that can cause errors in the final result. For example, the user can turn on the device by pressing a single button on the assay reader device. Thereafter, when the sample cartridge is inserted into the apparatus, the reading process can be automatically activated without further user input, and the inspection result can be determined and displayed based on the sample cartridge. In embodiments with network connectivity, the determined test results are automatically sent to a remote storage device such as a centralized database without requiring further user input, and then from the centralized database to a designated clinician, or It can be sent to another database, such as a hospital information system (HIS), a laboratory information system (LIS), or a database maintained by public health authorities such as CDC, FDA and WHO. In some embodiments with network connectivity, the determined test results can also be sent directly to a designated clinician or database. The remote storage device herein shall be a centralized database, HIS, LIS, public health authority database, designated clinician device, or any other data storage not physically coupled to the assay reader device Can do.

  The disclosed portable assay device can include a base assay analyzer such as a base assay reader device having a bay that houses a plurality of different modules. One module contains any necessary additional information such as patient identification information, type of examination, device operating mode, sample information, and any other additional examination information or patient information related to the examination performed by the IVD device. It may include a barcode scanner that is used when the user inputs. In some embodiments, the mode of operation of the device can be set by the number of clicks or the click pattern of a single button on the base assay analyzer. Another module can include a barcode scanner and even a network connection element. Such a modular design approach allows for the expansion of the functionality of the assay reader device, for example, enabling barcode scanning and wireless connectivity while the assay reader device maintains portability and cost advantages. The user gains the flexibility to determine the best functional capabilities needed for a unique setting or application by selecting different modules. The module can be any accessory of the base assay analyzer and the base assay analyzer functions with no module inserted to read the inserted assay, such as a lateral flow assay test strip You can also Modules can be exchanged between analyzers. The module can become an integral part of the analyzer when inserted.

  As described above, one of the modules includes a bar code reader and a communication element for network connection via, for example, a cellular modem, a wireless connection such as a satellite connection or Wi-Fi, or a wired connection. Can do. When such a module is inserted into an assay reader device bay and electronically communicates with the device's memory and / or processor, the assay reader device can send or upload data to a remote repository over a network. . Thus, remote devices or remote personnel can store and analyze such assay reader device test data alone or in a centralized manner. Modules with cellular or satellite modems can communicate directly with network elements or other IVD devices without the assay reader device requiring separate intervention or operation by the device user to transmit, store, analyze and A built-in mechanism for accessing a publicly available network, such as a telephone network or a cellular network, is provided to enable dissemination. For example, in some examples, electronic test results are automatically transmitted, stored, analyzed, and / or distributed during analysis of a patient sample by the assay reader device. In another example, electronic test results are transmitted, stored, analyzed, and / or distributed immediately after the patient sample is analyzed by the assay reader device. In some embodiments, a module can provide a connection to a cloud database, such as a server-based data store. A cloud-based connectivity module can allow universal connectivity of assay reader devices without the need for local network infrastructure.

  Device users can use the barcode scanner to customize the assay reader device to perform a variety of workflows that best fit their environment and compliance requirements. This bar code scanning technique provides a way for the end user to simply customize the diagnostic device without error. For example, to scan a barcode to set the mode of operation of the device or to comply with requirements such as medical institution standards, compliance standards, documentation standards, reporting standards, or any other requirement applicable to the laboratory environment You can specify the required information type.

  Additionally or alternatively, in some embodiments, the operating mode of the device can be set through a single button click count or click pattern of the base assay analyzer. For example, in some implementations, a single button press turns on the base assay analyzer and sets the analyzer to the default operating mode, and the instrument implements this default operating mode after the cartridge is inserted. can do. When the button is double-clicked, another operation mode different from the default operation mode can be started. If the user presses a single button in other numbers or patterns, instructions regarding the desired mode of operation can be provided to the processor of the device. Although the present description describes an embodiment of a base assay analyzer with reference to a single button, it allows the user to select and switch between operating modes of the device (but is not limited to, Other features (such as a single switch, knob, lever or handle) are possible.

  An example of the operation mode of the apparatus is an endpoint reading mode. In endpoint reading mode, the user prepares and cultures the assay outside the base assay analyzer and tracks the onset time of the assay. For example, an influenza assay can have an expression time of 10 minutes, so the user waits 10 minutes to apply a sample to the assay. The user inserts the assay into the base assay analyzer after 10 minutes and obtains the test result. Thus, when the base assay analyzer operates in the endpoint reading mode, after applying the sample to the assay, wait for a predetermined time until the assay is inserted into the base assay analyzer, eg, by voice or on a visual display. A command to instruct the user can be given. In other embodiments, the base assay analyzer does not display any instructions when operating in endpoint reading mode, and can simply read the assay upon insertion into the base assay analyzer. Once the assay is inserted into the base assay analyzer, the device's optical reader can collect image data representing the assay and be ready for analysis to determine the results of the assay. In some embodiments, the endpoint reading mode may be the default operating mode of the base assay analyzer.

  Another example of the operation mode of the apparatus is a walker mode. Thus, when operating in the simplified mode, the base assay analyzer can instruct the user to insert the assay immediately after or during application of the sample. In a simplified mode according to one embodiment, the assay can be inserted into the base assay analyzer as soon as the user applies the sample to the assay. The assay is expressed in the base assay analyzer, which can track the elapsed time since assay insertion. When a predetermined expression time has elapsed, the base assay analyzer can collect image data representing the assay, analyze the image data to determine the test results, and report the results to the user. The assay expression time can be specific to each test, for example, the influenza assay expression time can be 10 minutes and the streptococcal assay expression time can be 5 minutes. In some embodiments, the simple mode can be set by double-clicking a single button on the base assay analyzer. Additional input can also indicate the assay onset time to the reader device. For example, the type of assay inserted and the time of expression of the assay by a barcode scanned by the barcode reader of the insertion module, or a barcode provided on the assay or on the cartridge used to hold the assay Can be shown to the device. Based on the type of assay, the base assay analyzer can wait for a predetermined period of time after applying and inserting the sample to collect image data representing the assay.

  There are many advantages associated with the ability of the base assay analyzer implementation described herein to allow a user to select and switch between operating modes of the device. The endpoint reading mode can be useful in large laboratories or clinics where personnel are typically batch processing multiple tests. Simple mode does not want the end user to need to track assay expression time when performing a single test (or has no knowledge of how to accurately track assay expression time or such training) Can be useful). The simple mode is the result of false test results due to assay insertion and imaging being too rapid (too early to elapse for the onset of the assay) or too slow (too much time since the onset of the assay is over). Generation can be advantageously reduced or eliminated. Further, in simplified mode, for example when a dynamic graph of assay readings is desired, the assay reader can be operated to capture multiple assay images at predetermined time intervals.

  One embodiment of the disclosed base assay analyzer, such as the base assay reader device described in detail below, has a single housing such as a single power button on its outer housing that powers the base assay analyzer on and off. Only the button is included. The disclosed base assay analyzer embodiments also implement two different device operating modes (although more than two device operating modes are possible). The base assay analyzer can include instructions that implement a double-click function on the power button to allow the end user to select and switch between the two instrument operating modes. After receiving the button press once and turning on the instrument, the endpoint reading mode can be automatically initiated when the assay cartridge is inserted. The processor of the device can initiate a store instruction to execute the simplified mode upon receiving input by the user double clicking on the power button. This double-click feature provides a way for the user to simply and intuitively switch between the various operating modes of the base assay analyzer. This double-click feature also allows the user to configure the device in real time to operate in the simplified mode without requiring any further setup steps or further programming of the base assay analyzer by the user. Instead of or in addition to a double click that initiates a secondary (non-default) instrument operating mode, the base assay analyzer may, for example, indicate that the user has pressed any button a certain number of times, It will be understood that there may be instructions for recognizing other click modes, such as recognizing that the button was pressed in a pattern and / or that the button was held down for a predetermined time.

  As noted above, other barcode usage examples include patient identification information, test type, device operating mode, sample information, and any other additional test information or patient information related to tests performed by the IVD device. Providing additional data for associating with test result data. Some bar codes can unlock device functions. Some barcodes may provide or update various types of information that the device uses to analyze assays, determine test results, or perform functions. For example, the scanned barcode can provide the reader device with assay or reader calibration information that is useful or necessary for performing the test. In embodiments where the device does not have wireless network connectivity, the test results can be stored in the device's memory, and the user can use a barcode scan to access the stored test results. Can be scanned.

  Although the disclosed device is generally described herein as an assay reader device, the modular system design and network connectivity aspects described herein can be implemented in any suitable in vitro diagnostic device. Will be understood. For example, the features described herein can be implemented in a reader device that analyzes other types of assays, such as but not limited to molecular assays, to provide diagnostic test results.

  Various embodiments are described below with reference to the drawings for purposes of illustration. It is to be understood that the disclosed concept is capable of many other implementations and that the disclosed implementation can provide various advantages.

Overview of Assay Reader Device and Example Operation FIG. 1A shows a series of example components of an assay reader system 100. These series of components include a barcode module 120 and a barcode and connectivity module 110 that can be locked into the bay 132 of the base assay reader device 130 and an assay 144 that is inserted into the base assay reader device 130. A cartridge 140 for holding the cartridge. FIG. 1B shows an assembly example of the base assay reader device 130 in which the cartridge 140 is inserted into the cartridge accommodation opening 134 of the reader 130 and the barcode module 120. In the following description, the components of FIGS. 1A and 1B will be described together.

  The base assay reader device 130 includes a bay 132 that locks and optionally releasably receives one of a plurality of different modules, a cartridge receiving opening 134, a display 136, and a single button 138. Including. The bay 132 may include mechanical features that lock and mate with the mechanical features of the corresponding insertion module and electrical features that establish electronic data communication between the components of the insertion module. . The base assay reader device 130 can provide basic assay analysis and data storage functions without an insertion module, and can select and insert an insertion module to extend these basic functions. . In embodiments where no module is inserted, a cover may be provided over the opening of the bay 132. For example, the device 130 can have a cover from the beginning, which can be removed and one of the replaceable modules inserted.

  The cartridge receiving opening 134 can be sized and shaped to align the assay test area with a detector or detector array provided in the device 130 when the assay is inserted through the cartridge receiving opening 134. . For example, if the assay is a lateral flow assay test strip, the test region can include one or both of a control zone and a test zone having an immobilized compound that specifically binds the target analyte. The detector can implement an adaptive readout technique that improves the specificity of the test results by compensating for background and non-specific binding and reduces false positive results. The base assay reader device 130 can be configured to perform the assay quickly and accurately as a digital immunoassay configured to detect, for example, type A + B influenza, RSV and group A streptococci within 10 minutes. . This can assist in quick diagnosis and facilitate a test-and-act-approach while the patient is in the examination room.

  The display 136 of the base assay reader device 130 can be an LED, LCD, OLED or other suitable digital display, and in some embodiments can implement touch sensing technology. The button 138 may be a mechanical button for powering on the base assay reader device 130. As described above, the device can include instructions for recognizing a pattern in which a single button 138 has been pressed to select an operating mode of the device. As will be described in more detail below, the button 138 can provide the user with secure one-touch wireless electronic medical record synchronization when the connectivity module is inserted into the bay 132 of the device. For example, pressing this simple one-touch button once (or pressing in a fixed pattern) prepares the base assay reader device 130 for use, stores test result data in the device memory, and passes the test results to the patient through the connectivity module. Can be transferred to electronic medical records. Other embodiments of the device 130 can be automatically turned on and ready for use when plugged in or otherwise powered, and thus the button 138 can be omitted. In other embodiments, multiple buttons may be provided on the device 130. As described in further detail below, the assay reader device can further include a processor and at least one memory. The base assay reader device 130 can also support data storage and printing.

  The barcode module 120 includes a barcode scanner 122. The barcode scanner 122 can include one or more photodetectors and optionally a light emitting element to read the barcode. For example, one implementation of a barcode scanner 122 includes a light source, a lens for concentrating the light source on an object, and an optical sensor for receiving light reflected from the object and converting the received light into an electrical signal. Can be included. Some implementations of the bar code scanner 122 sensor may include an array of many micro light sensors that produce a voltage pattern that is substantially identical to the bar code pattern. The barcode scanner 122 analyzes the image data provided by the sensor, identifies the barcode pattern in the image data, determines the content associated with the barcode pattern, and outputs the content to the processor of the assay reader device, for example. A decoder circuit or decoder software may also be included. Barcode module 120 establishes electronic data communication between mechanical features that engage and engage corresponding features in bay 132 of base assay reader device 130 and components of base assay reader device 130. And an electronic feature.

  Although not shown, the barcode module 120 may also include information elements such as storage elements or other active or passive electrical components. Passive information elements can include transistor networks, PROMs, ROMs, EPROMs or other programmable memories, EEPROMs or other reprogrammable memories, gate arrays and PLAs, to name just a few. This information element functions to identify the capability of the barcode module 120 to the assay reader and / or authenticate the barcode scanning capability of the barcode module 120 as a module from a particular source or manufacturer. Can do.

  Barcode module 120 can reduce manual transfer and error risk while ensuring high levels of traceability and quality control through customizable documentation functions, data storage / downloading and printing capabilities. As used herein, traceability can mean the ability to verify, with documented information, location, time, staff, patient or other information related to an examination performed using a reader device. Documented information can be advantageously accessed by a number of entities in a number of ways as described herein. As described above, the barcode scanner can be used to enter examination related data, change device settings, unlock data access or other functions, or change device modes. Test related data may include, among other test related information described herein, a user ID, clinician ID or tester ID, sample ID, and test kit lot and / or expiration date. The multiple modes of operation of the assay reader device provide a flexible workflow performed through barcode scanning.

  In terms of traceability, hospitals, clinics, laboratories or other medical institutions have internal standards that specify the type of information that needs to be recorded for each test performed so that the test results comply with applicable rules. Can do. Bar code scanners can allow the clinician performing the test to enter the necessary information by scanning the bar code. In some implementations, the barcode scanning module will output a list of required information types associated with each test, or enter any required information that was not scanned before the test results were transmitted and stored It can be programmed in advance to output a prompt to the user. In some implementations, a barcode scanning module with connectivity can communicate with a centralized database to provide a list of required information types. The required information type can be displayed to the user by wireless communication from the centralized database to the base assay reader device. The user can enter the required information type by scanning one of a plurality of available bar codes provided using the bar code scanning module. When a barcode associated with the required information type is scanned, the test results are associated with this input information, in some cases automatically and / or wirelessly secured to the laboratory information system and / or electronic medical records Can be sent. Thus, the test results sent to the laboratory information system and / or electronic medical records can include (but are not limited to, user ID, clinician ID or tester ID, sample ID, and test kit lot and Automatically associated seamlessly with information (such as expiration dates) to greatly enhance the traceability of test results obtained using the methods and systems described herein.

  In some embodiments, the base assay reader device may allow an end user to configure a preset function, such as whether a patient ID barcode scan or operator ID barcode scan should be required at the start of each test. Can be. Configuration of these preset functions can be done by scanning a configuration barcode that includes instructions for preset function scan configuration when decoded by the device. In one implementation, the health care facility administrator first selects one or more barcodes from a series of printed barcodes corresponding to the type of information required for the particular reader device configuration he desires. After this initial configuration selection, a user using that particular reader device in the medical facility may scan the appropriate bar code and enter information corresponding to the function of the preselected reader device. it can. The reader device can send all available information related to the examination to the central server, for example via a connectivity module or a wired connection to another computer device. In one implementation, compliance may not be enforced at the reader level, and this information is sent with the test results if the end user provides the patient ID through a barcode scan, otherwise the patient ID field is left blank. Left behind. Other implementations can prompt the end user for unknown information. If the reader does not have wireless or cellular connectivity capabilities, local data storage, download and printing options can assist with compliance and traceability compensation.

  Illustrating advantageous customization options using one non-limiting example, an administrator in the clinic selects data categories A, B, and C and sends a report containing data corresponding to these categories. The administrator in the emergency treatment center selects data categories A, B, D, and E, and transmits a report including data corresponding to these categories. Thus, the reader device in the center can be configured. The ability to customize reports can significantly reduce administration time and record retention time. The acquired data can also meet applicable compliance standards because the chances of human error being incorporated into the report are reduced.

  FIG. 6 shows an example of display text that can be presented to the operator of the assay reader device. As described above, the system and method embodiments described herein allow end-users to customize the type of information stored in association with a test result on a particular assay reader device, thereby enabling test result compliance. And significantly improve traceability and reduce transcription and documentation errors. In embodiments that include wireless or cellular connectivity capabilities, customized reports that include test results associated with the selected information category can be automatically sent to a remote server. The display at the top of the first column of the display example of FIG. 6 is configured so that a specific type of information is associated with the inspection result, or a specific type of information is not associated with the inspection result. Fig. 5 shows a display of an assay reader device that prompts the user to scan a bar code. In this non-limiting example, after the user reads the prompt “Scan Configuration Barcode”, the assay reader device (if the user wishes to store operator ID information associated with the test results) Scan the barcode that instructs the operator ID function to be enabled, or (if the user does not want to store the operator ID information associated with the test result) the operator ID function on the assay reader device. Scan a bar code that instructs it to be invalidated. The assay reader device displays text confirming the user's selection after the user scans the bar code to indicate his selection. In this non-limiting example, the assay reader device displays “operator ID scanning enabled” or “operator ID scanning disabled” to the user. The assay reader device can then ask the user to enable or disable other types of information functions such as, but not limited to, sample ID and kit lot ID (eg, the display of FIG. 6). Refer to the test example).

  If the operator ID function is enabled, the assay reader device prompts the user to scan a bar code associated with the operator ID for each future test event. For example, the assay reader device may display a “scan operator ID” to the user before prompting the user to insert an assay test strip into the device for analysis and a bar associated with the user's operator ID. Instruct the user to scan the code. The assay reader device can continuously query the user to enter certain types of information according to the customized configuration settings of the device selected so far. For example, if the assay reader device is configured to request sample ID information, after the user scans the barcode associated with the operator ID, the next time the barcode associated with the sample ID for that test event is displayed. The user can be prompted to scan (see, eg, the “Scan Sample ID” display in FIG. 6). In some examples, the assay reader device does not prompt the user to enter an assay test strip for analysis until all information required for a particular configuration has been entered. In some examples, the assay reader device can display a summary of configuration settings (see, eg, the display example at the top of the center column of FIG. 6).

  The customizable reporting function can be processed on the server side or by one or more remote computer devices that are physically separate from the reader device but receive information from the reader device. For example, test result data and related information from scanned barcodes can be stored in a database of one or more remote computer devices, such as a server system, where the remote computer device is customized to include only the field of interest. Generated reports can be generated for end users. End users may include, but are not limited to, reader device users, administrators using reader devices in medical facilities, entities that manage remote server systems, and public health organizations.

  Non-conforming test results can be flagged in the database (eg, fields for any information required for internal standards or application rules of medical organizations are blank). In some examples, but not limited to, non-compliant test results from a specific batch or lot of test strips, non-compliant information sent with test results from a particular health care provider or test location, and Statistical analysis of non-conforming results can be performed to identify the cause of general non-conformities such as non-conformances related to reporting frequency or some other deficiency. In some embodiments, such information can be automatically provided to health care managers to help create a plan to ensure adherence to compliance standards. Information collected from multiple different operators, facilities or medical organizations, for example, to identify and track infection trends so that a disease management plan can be developed if they meet specified information type requirements By standardizing, it is possible to increase the significance of statistical analysis of the matching test results.

  The barcode and connectivity module 110 further includes a barcode reader 112 as described above, and includes a connection device that is graphically represented by a connectivity marker 114. The connecting device may be a wireless communication device such as a cellular modem that accesses a publicly provided and publicly maintained data network. The publicly provided network can be a public telephone network, a public cellular network, or another suitable type of publicly available data network. The bar code and connectivity module 110 establishes electronic data communication between components of the base assay reader device 130 and mechanical features that lock and engage corresponding features in the bay 132 of the base assay reader device 130. And an electronic feature. This can reduce administrative burdens and overhead, and can help reduce or minimize errors associated with manual result documentation and recording.

  Although not shown, the barcode and connectivity module 110 can include information elements as described above. This information element identifies the barcode scanning and network connectivity capabilities of the barcode and connectivity module 110 to the assay reader device and / or identifies the barcode and connectivity module 110 from a particular source or manufacturer. Can function to authenticate as a module.

  Barcode and connectivity module 110 provides all the functions and benefits of barcode module 120 and can provide cellular or other wireless connectivity. Such connectivity can be used to document test results across multiple sites and integrate with electronic medical records (EMR) HIS, LIS, and / or other medical record databases. For example, in some embodiments, test results can be sent to a server-based centralized database and then transferred to an appropriate medical records database, hospital database, or laboratory database. Sending the test results automatically can ensure that the results are automatically documented in the patient record. Also, by automatically transmitting the test results, it is possible to alert a designated medical staff member such as a patient care physician in real time about a potentially dangerous health condition of the patient. Furthermore, by automatically transmitting test results to a public health organization, the test result data can be aggregated and analyzed in real time to identify infectious disease trends, and in some cases can be suppressed. Such transmission of medical information can be done through a secure end-to-end connection that conforms to HIPAA, HITECH, ISO 27001: 2013 cybersecurity guidelines or other industry standards. Cellular or satellite connectivity can allow high-speed transmission of test results even from locations outside the standard clinical environment.

  The cartridge 140 can correctly align and secure the assay 144 within the base assay reader 130. As shown, the cartridge 140 can include a window that exposes the test area of the assay 144. The assay 144 can be an immunoassay that implements metal colloidal particle technology that provides, for example, sensitivity and powerful test performance. Alternatively, assay 144 can be a bioassay, a ligand binding assay, or any other type of diagnostic test that can be optically imaged to determine test results. The cartridge 140 can also include a barcode 142 that provides test information, such as test types, that in some embodiments can be used to configure an automated process for determining the results of an assay performed by the device 130. The user can enter information into the base assay reader device 130 as a barcode scanner on a module engaged with the base assay reader 130, such as a barcode module 120 or a barcode scanner on the barcode and connectivity module 110. Can be used to scan the bar code 142 of the cartridge 140. Such information may include one or more of patient and / or physician identification information, information regarding assay tests, and a bar code password for deactivating the base assay reader device 130. it can.

  The base assay reader device 130 can include one or more additional data communication ports (not shown) such as, for example, a USB port. This port can be configured as a general purpose hardware interface for the base assay reader device 130. Base assay reader device 130 can use this interface to support external peripherals such as printers or keyboards. This port can connect the base assay reader device to a PC for data download. For example, the base assay reader device can function like a USB drive when connected to a PC via a USB interface. The end user can also update the firmware of the reader device by connecting a USB drive including the latest version of firmware to the USB port. In addition, this USB port also provides a convenient way to upload assay calibration data, such as lot-specific calibration data, to the reader device.

  Although not shown, additional module options such as connectivity modules that do not have a bar code mechanism, wired connection modules, and modules that have an electrical storage function to extend the battery life of the device, to name just a few Can also be used. In some embodiments, this module is a printer or can include a printer. In some embodiments, the module is a separate detection unit or can include a separate detection unit. Such a detection unit module can be used to perform the same or different types of tests as the base assay reader device 130. In some embodiments, this module can be an incubator that incubates the assay before determining the test results. For example, in a lateral flow assay, the incubator module is used to hold the assay and present the expression time before presenting the user with a reminder or instruction to remove the cartridge and insert it into the base assay reader device 130 for reading. Can be tracked. For molecular assays, the incubator module can be used for sample preparation and culture.

  Next, FIG. 2 shows a schematic diagram of one networked embodiment of the system 200. In the illustrated embodiment, arrows between some devices and a public wide area network (WAN) 220 or public network 230 are configured such that such devices are involved in two-way communication over such networks. Indicates that For example, if a network element shown in FIG. 2 is accompanied by an arrow indicating the network element and the public network 230, the device is configured to send and receive data to and from another device over the public network 230. ing.

  In FIG. 2, the example of the schematic of the patient treatment facility 202 is shown. Patient treatment facility 202 may represent a patient facility such as a hospital, examination room, or clinic that applies or provides one or more diagnostic tests to a patient. In the illustrated embodiment, the patient treatment facility 202 is shown to include or include a hospital information system (HIS) database or a laboratory information system (LIS) database 203. That is, in the illustrated embodiment, the patient treatment facility 202 maintains or otherwise provides access to the HIS or LIS database 203. In the illustrated embodiment, the HIS or LIS database 203 is a repository for test results, summary reports, or other data about the patient utilizing the patient treatment facility 202. In various embodiments, the HIS or LIS database 203 is further coupled to one or more processors (not shown) that perform specific processing tasks such as analysis of data stored in the database.

  In the illustrated embodiment, the patient treatment facility 202 further includes a plurality of in vitro diagnostic (IVD) devices 204a, 204b, and 204c. However, the network environment 200 can also include IVD devices outside the patient treatment facility environment, as indicated by the IVD device 204d. In one embodiment, an IVD device is configured to optically image a lateral flow assay test strip to which a biological sample has been applied and to determine diagnostic test result information based on image data representing the test strip. Diagnostic inspection equipment such as. It should be understood that any suitable IVD device can be advantageously used with the disclosed system.

  As further shown in FIG. 2, each IVD device 204a, 204b, 204c, and 204d may include a network communication device 205a, 205b, 205c, or 205d, respectively. For example, the network communication devices 205a, 205b, 205c, and 205d are through an insertable accessory module that includes a cellular modem or another transceiver device configured to communicate with a public network such as the public wide area network 220 or the public network 230. Can be provided. In one embodiment, network communication devices 205a, 205b, 205c, and 205d allow each IVD device to communicate with each other or with another network element as disclosed herein. Also, in one embodiment, network communication devices 205a, 205b, 205c and 205d allow each IVD device to store data indicating diagnostic test results and / or remote such as HIS or LIS database 203 for further analysis. Can communicate with resources. Although not shown, some IVD devices may include a barcode scanner module such as barcode module 120 that does not have network connectivity. The results stored by such a device can be transmitted via the network 230, 220, for example on a HIS / LIS, patient computer or another computer device via a USB connection and a suitably scanned barcode password. You can upload to one or more of them.

  The system 200 of FIG. 2 indicates by arrows 221 that the patient treatment facility 202 (and the IVD device / HIS or LIS database contained therein) is configured to communicate over the public wide area network 220. In one embodiment, one or both of the public wide area network 220 and the public network 230 at least partially restrict access to the network. Further, as described herein, in one embodiment, the disclosed system 200 enables communication with a patient treatment facility via an encrypted or other secure data transmission protocol.

  System 200 further includes a patient computer 206, a health institution computer 208, an insurance provider computer 210, and a device manufacturer computer 212. Each of these network elements can communicate with each other and with the patient treatment facility 202 via the public wide area network 220 as indicated by arrows 222, 223, 224, and 225, respectively. Arrow 226 indicates that public wide area network 220 can communicate with another type of public network 230, such as the Internet. Accordingly, the devices shown in FIG. 2 are configured to communicate with each other over public wide area network 220, public network 230, or some combination thereof.

  In the illustrated embodiment, each of these computers enables communication with device maker computer 212, IVD devices 204a, 204b, 204c, and HIS or LIS database 203 by various organizations. For example, the patient computer 206 allows the patient to communicate with the device manufacturer computer 212, the health agency computer 208 allows the communication with the patient treatment facility 202 by one or more health agencies, and the insurance provider computer 210. Allows communication with the patient treatment facility 202 by the insurance provider, and the device manufacturer computer 212 allows communication with the patient treatment facility 202 by the manufacturer of the IVD device. The device manufacturer computer 212 communicates with the data server 212a with which the IVD devices 204a, 204b, 204c and 204d are coupled to the device manufacturer computer 212 to provide necessary data such as calibration data, firmware or other software, and data upgrades, among others. Can be received when necessary.

  In various embodiments, the system 200 enables transmission and exchange of data including inspection results and additional data transmitted with the inspection results. For example, data transmitted between the various network elements of the system 200 can include diagnostic data and information, network information, hardware information, and environmental information as described above. In one embodiment, some or all of the data transmitted between the various elements of the illustrated system 200 is encrypted to prevent undesired access to the transmitted data. This encryption not only protects the data from interception and unwanted consumption, but also verifies or maintains the integrity of the transmitted data, such as by providing a checksum or other mechanism that ensures receipt of all transmitted data You can also

  In one embodiment, patient computer 206, health care organization computer 208, insurance provider computer 210, and device maker computer 212 are standard desktop or laptop computers accessible by appropriate organizations. In another embodiment, one or more of the patient computer 206, health institution computer 208, insurance provider computer 210, and device manufacturer computer 212 may handle large amounts of data and / or complex processing. A mainframe computer or server computer configured to provide routines and analysis routines. In this embodiment, the appropriate entities involved in the illustrated computer device (eg, the insurance company involved in the insurance provider computer) are uploaded from the IVD device and stored in the system, depending on the user's access purpose. You can access some or all of your data. In another embodiment, one or more of the patient computer 206, health institution computer 208, insurance provider computer 210, and device manufacturer computer 212 allow the user to access data from the handheld portable device. A portable computer such as a personal digital assistant (PDA) or a cellular phone configured as described above. In one embodiment not shown, one or more medical professionals, such as medical personnel belonging to a patient treatment facility 202, use a suitable handheld device, such as a PDA, cell phone, or other handheld portable device. Access the data communicated by the IVD devices 204a, 204b, 204c and 204d. In this embodiment, immediately after a patient sample is analyzed by a diagnostic test using an IVD device, appropriate medical personnel can access or actively know such data. It should be understood that in various embodiments, entities other than those of the network elements shown in FIG. 2 can also access data uploaded by the IVD device, depending on the need to perform their respective tasks. .

  As described above, in one embodiment, the IVD device is configured to upload data to one or more database servers. These database servers can be configured to archive test results, aggregate test results into a summary report, or analyze test results for spatial correlation, temporal correlation, or other correlation. These database servers can also be configured to perform other analyzes on the data depending on the type of data uploaded and the purpose of the organization that manages and implements the database server. The ability of an IVD device to upload data directly to a database server via the disclosed connectivity module provides several advantages of the disclosed system. First, the patient care facility obtains test results from the database server via a secure internet connection or other network connection and stores the retrieved results in its own database (eg, its own HIS or LIS database). Can do. Aggregate inspection reports made available by database server processing are also beneficial to public health authorities such as CDC, FDA and WHO. Such reports can be provided in real time by the ability of the disclosed IVD device to automatically communicate diagnostic test results directly to the database server.

  FIG. 3 is a schematic block diagram of one possible embodiment of the internal components of an example assay reader device 300. These components may include a processor 310 coupled to memory 315 for electronic communication, working memory 355, cartridge reader 335, module interface 345, and display 350.

  The module interface 345 may include circuitry that reads information from the information elements of the inserted module and forwards it to the processor 310 for analysis or verification. Accordingly, the module interface 345 can provide a first signal path that can be used by the apparatus 300 to identify characteristics of the connection module that indicate the presence and connection capability of the barcode scanner in the connection module. The module interface 345 may also include a path to establish electronic communication with the inserted module's barcode reader, network transceiver, power supply or other electronic component. Accordingly, the module interface 345 may provide a second signal path configured to receive from the connection module barcode data representing the barcode imaged by the connection module and / or information or instructions represented by the barcode. .

  The cartridge reader 335 reads one or more light detections for reading any assay held in the inserted cartridge and optionally reading any information such as a barcode printed on the inserted cartridge A vessel 340 can be included. The cartridge reader 335 can transmit this image data from one or more photodetectors to the processor 310 so that the image data representing the imaged assay can be analyzed to determine assay test results. Further, the cartridge reader 335 can be used to determine which of a plurality of automated operating methods for imaging the assay and / or analyzing the image data of the assay should be implemented. Image data representing the imaged cartridge can also be transmitted from one or more photodetectors. The photodetector (s) 340 is an electrical signal representing incident light, such as a PIN diode or array thereof, a charge coupled device (CCD) or a complementary metal oxide semiconductor (CMOS) sensor, to name just a few. Can be any device suitable for generating. The cartridge reader 335 may also include components for detecting cartridge insertion, such as mechanical buttons, electromagnetic sensors, or other cartridge sensing devices. The indicator from this component can instruct the processor 310 to initiate an automated assay reading process without further input or commands from the user of the device 300.

  As described in more detail below, the processor 310 performs various processing operations on the image data received from the cartridge reader 335 and / or the module interface 345 to determine and store test result data. It can be constituted as follows. The processor 310 may be a general purpose processor that implements assay analysis functions, or a processor specifically designed for assay imaging and analysis applications. The processor 310 can be a microcontroller, a microprocessor, or an ASIC, to name just a few, and can include multiple processors in some embodiments.

  As shown, processor 310 is connected to memory 315 and working memory 355. In the illustrated embodiment, the memory 315 stores a module recognition element 320, an inspection result determination element 325, a data communication element 330, and an inspection data repository 305. These modules include instructions that configure the processor 310 of the device 300 to perform various module connection tasks, image processing tasks, and device management tasks. A working memory 355 can be used by the processor 310 to store a working set of processor instructions contained in a module of the memory 315. Alternatively, working memory 355 can be used by processor 310 to store dynamic data created during operation of device 300.

  As described above, the processor 310 can be configured by a plurality of modules stored in the memory 315. Module recognition element 320 can include instructions that control electronic communication between the processor and module interface 345. For example, the module recognition element 320 includes instructions that call a subroutine to configure the processor 310 to read the information element of the inserted module to authenticate the module as being compatible with the device 300 and determine its capabilities. be able to. The test result determination element 325 may include instructions that call a subroutine to configure the processor 310 to analyze the assay image data received from the photodetector (s) 340 to determine the result of the assay. For example, the processor can compare the image data with a plurality of templates or pre-identified patterns to determine inspection results. In some implementations, the test result determination element 325 performs a adaptive reading process on the image data from the photo detector (s) 340 to compensate for background and non-specific binding. Thus, it is possible to improve the specificity of the test result and reduce the false positive result.

  The data communication element 330 can determine whether a module that enables wireless data transmission has been inserted into the device, and can manage the transmission of test result data to established personnel and / or remote databases. For example, the transmission of test result data can be based on barcode data received with the assay image, where the assay image is used to generate a test result and stored in association with the test result, and the barcode Data is also stored in association with the inspection result. If the device 300 is not coupled to a network communication enabled module, the data communication element 330 can store test results and related information locally in the test data repository 305. If a local wired or wireless connection is established between the device 300 and another computer device, such as a hospital computer, clinician computer or patient computer, the data communication element 330 will send the user of the device 300 within the repository 305. To access the data, the inserted module can be prompted to scan the password barcode.

  The processor 310 can be configured to control the display 350 to display, for example, captured image data, captured bar codes, test results, and user instructions. Display 350 can include a panel display, such as an LCD screen, LED screen, or other display technology, and can implement touch-sensing technology.

  The processor 310 may write data to the data repository 305, for example, data representing barcodes and captured images of the assay, instructions or information associated with the imaged barcodes, and determined test results. Although the data repository 305 is illustrated as a conventional disk device, those skilled in the art will appreciate that the data repository 305 can be configured as any storage media device. For example, the data repository 305 can include a disk drive such as a hard disk drive, optical disk drive, or magneto-optical disk drive, or solid state memory such as flash memory, RAM, ROM, and / or EEPROM. The data repository 305 can also include a plurality of storage devices, any one of which can be configured to reside within the assay reader device 300 or can be external to the device 300. You can also For example, the data repository 305 can include a ROM memory that includes system program instructions stored in the assay reader device 300. The data repository 305 can also include a memory card or high-speed memory that can be removed from the device 300 configured to store captured images.

  Although FIG. 3 shows a device having a single component including a processor, cartridge reader, module interface and memory, those skilled in the art will recognize these single components to achieve a specific design objective. It will be appreciated that can be combined in various ways. For example, in another embodiment, memory elements can be combined with processor elements to save cost and improve performance.

  FIG. 3 also shows a plurality of memory elements including a memory 315 having a plurality of modules and a separate memory 355 having a working memory. Embodiments will be recognized. For example, one design may utilize ROM memory or static RAM memory to store processor instructions that implement the modules contained in memory 315. Processor instructions can also be loaded into RAM for ease of execution by processor 310. For example, working memory 355 may include RAM memory and instructions may be loaded into working memory 355 prior to execution by processor 310.

  FIG. 4 is a flowchart illustrating an example method 400 of operation of the assay reader device disclosed herein. In some embodiments, the method 400 can be performed by the assay reader device 130 and / or the processor 310.

  At block 405, the processor 310 can receive a power-on indication in response to, for example, a user pressing a single button located on the assay reader device.

  At block 410, the processor can identify whether a module is inserted in the bay of the assay reader device and, if so, the capabilities of the inserted module. As described above, these capabilities can include one or both of barcode scanning and network connectivity including cellular or satellite network connectivity.

  At decision block 415, the processor 310 can identify whether the capability of the inserted module includes barcode scanning or barcode scanning and network connectivity.

  If the inserted module's capabilities include barcode scanning, the method 400 may move to block 420 to receive input via the barcode scanner of the inserted module. Such input may include information that is stored in association with test results and / or information that constitutes the operation of the assay reader device, such as instructions relating to an imaging procedure for obtaining image data of the inserted assay, for example. Can do. In some embodiments, the operation of the device can be configured by a pattern of pressing buttons as described above. At block 425, the method 400 may include receiving an assay test holding cartridge within the receiving opening of the assay reader device, imaging the assay, and determining a test result based on image data representing the assay. Block 425 may be implemented as any of the disclosed reader modes of operation, such as, but not limited to, endpoint reading mode or simplified mode. At block 430, the processor 310 can display and store the test results and any associated data locally.

  At decision block 435, the processor receives, for example, an indication that additional barcodes have been scanned (by returning to block 420) or that additional cartridges have been inserted (by returning to block 425). It can be determined whether further inspection should be performed. In such an example, the method may loop again with blocks 420-430 in the order shown, or with blocks 420 and 425 swapped.

  If the capability of the inserted module includes barcode scanning and network connectivity, the method 400 may move to block 440 and receive input via the barcode scanning of the inserted module. Such inputs may include information stored in association with test results, and / or instructions relating to imaging procedures for obtaining image data of inserted assays, or instructions relating to where test result data should be transmitted, etc. Information constituting the operation of the assay reader device may be included. In some embodiments, the operation of the device can be configured by a pattern of pressing buttons as described above. At block 445, the method 400 may include receiving an assay test holding cartridge in the receiving opening of the assay reader device, imaging the assay, and determining a test result based on image data representing the assay. Block 445 may be implemented as any of the disclosed reader operating modes, for example, endpoint reading mode or simplified mode.

  At block 450, the processor 310 displays the test results and any associated data such as, for example, the assay image used to generate the test results and additional information provided via the scanned barcode. And can be stored locally. In addition or alternatively, the processor 310 may display the test results and optionally any relevant data and send it to the destination database or person over the network. For example, in some embodiments, this transmission can occur through the connectivity module 110 inserted into the base assay reader device 130 and in electronic communication with the base assay reader device 130.

  At decision block 455, the processor receives, for example, an indication that additional barcodes have been scanned (by returning to block 440) or that additional cartridges have been inserted (by returning to block 445). It can be determined whether further inspection should be performed. In such an example, the method may loop again with blocks 440-450 in the order shown, or with blocks 440 and 445 swapped.

  If at either block 435 or 355, the processor 310 determines that no further testing should be performed (eg, because any sensor in the assay reader device is not activated), the method 300 proceeds to block 460. Transition. At block 460, the processor 310 may turn off the assay reader device after waiting for a predetermined time interval.

  FIG. 5A shows an example hospital workflow that does not use wireless point-of-care testing solutions. As shown, samples are collected and test results are provided at the clinical site. The reader device embodiments described herein can provide test results within 10 minutes. The results are then manually documented in a logbook and manually entered into a laboratory information system or electronic medical record for manual documentation of results. After entering the results into the laboratory information system or electronic medical record, the physician can access the test results to treat the patient. In such a workflow, the physician must wait for manual documentation to complete before reviewing the test results and treating the patient.

  FIG. 5B illustrates an example hospital workflow that implements a streamlined workflow through an assay reader device of the present disclosure that provides a wireless point-of-care test solution. As shown, samples are collected and test results are provided at the clinical site. Embodiments of the reader device including the network communication enabled module described herein can provide test results within 10 minutes. These results are automatically sent directly from the clinical site over the network to the laboratory information system or electronic medical records. The transmitted results can facilitate rapid patient treatment by being immediately available to the clinician via a laboratory information system or electronic medical records. This workflow allows the patient's test results to be accessed while the patient is still in the examination room without having to wait for manual documentation of the test results, thereby enabling faster patient treatment.

  One advantage of the base assay reader device described herein is that it can provide a scalable platform that meets the needs of an increasing number of healthcare organizations, for example by providing a new module to upgrade each device at any time. is there. The base assay reader device can also incorporate other test platforms and instruments via the module receiving bay. In addition, a single assay reader device can be used for multiple functions via interchangeable modules. In one example, a health service provider may purchase and use a base assay reader device that does not include any of the modules described. This provider may choose one or more, depending on the need to meet its specific needs, when expanding its capabilities, when more advanced features are needed, or when additional purchasing resources become available Modules can be purchased. Modules can be inserted into the base assay reader device to quickly and easily expand the functionality of the device without modifying the previously acquired assay reader device. As another example, after a health care provider purchases a kit with a base assay reader device and one or more modules, a new barcode scanner module with additional functionality may be developed. The provider can purchase a new barcode scanner whenever he wants and can replace the old module with a new module while continuing to use the already acquired base assay reader device. In another example, a barcode scanner or some other component in the module may malfunction or break. A spare barcode scanner can be used with the base assay reader device while the first barcode scanner is being repaired.

  Another advantage of the presently disclosed base assay reader device with a network connectivity module is the rapid delivery of test results through the integration of a single access point with an electronic medical records and laboratory information system, while the patient is in the field. It is a point that enables decision making. This automatic documentation can facilitate faster patient treatment by speeding up access to test results by the doctor and providing the results to the doctor almost immediately after the test is completed, regardless of the location of the test. The base assay reader device of the present disclosure that includes a barcode scanning module reduces transcription errors compared to systems that require manual identification information input.

System Implementation and Terminology The implementation disclosed herein provides a system, method and apparatus for a modular reconfigurable assay reader. One skilled in the art will recognize that these embodiments can be implemented in hardware, or a combination of hardware and software, and / or in firmware.

  The assay reader device may include one or more image sensors, one or more image signal processors, and a memory that includes instructions or modules for performing the methods described above. The apparatus includes data, a processor that loads instructions and / or data from memory, one or more communication interfaces, one or more input devices, and one or more output devices such as a display device, A power supply / interface. The apparatus can further include a transmitter and a receiver. The transmitter and receiver can be collectively referred to as a transceiver. The transceiver can be coupled to one or more antennas for transmitting and / or receiving radio signals.

  The functionality described herein can be stored on a processor-readable medium or computer-readable medium as one or more instructions. The term “computer-readable medium” refers to any available medium that can be accessed by a computer or processor. By way of example, and not limitation, such media may include RAM, ROM, EEPROM, flash memory, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage device, or any desired program code instructions or data structure Any other medium that can be used to store and accessible by the computer can be included. As used herein, discs (disk and disc) include compact discs (“CD”), laser discs, optical discs, digital versatile discs (“DVD”), floppy discs and Blu-ray discs. In this case, the disk reproduces normal data magnetically, and the disc reproduces data optically using a laser. Note that the computer-readable medium may be a tangible non-transitory medium. The term “computer program product” means a combination of a computer device or processor and code or instructions (eg, a “program”) that can be executed, processed, or calculated. The term “code” as used herein refers to software, instructions, code, or data that can be executed by a computing device or processor.

  Various exemplary logic blocks and modules described in connection with the embodiments disclosed herein include general purpose processors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs). ), Or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination of these designed to perform the functions described herein. be able to. A general purpose processor may be a microprocessor, but in other examples, the processor may be a controller, microcontroller, or state machine, or a combination of these. A processor is a combination of computer devices, such as a combination of a DSP and a microprocessor, a combination of multiple microprocessors, a combination of one or more microprocessors and a DSP core, or any other such configuration. It can also be implemented. Although described herein primarily with respect to digital technology, a processor may also include primarily analog elements. For example, any of the signal processing algorithms described herein can be implemented with analog circuitry. Computer environments include, but are not limited to, microprocessor-based computer systems, mainframe computers, digital signal processors, portable computing devices, electronic notebooks, device controllers, and appliances, to name but a few. Any type of computer system can be included, including any computing engine.

  The methods disclosed herein include one or more steps or actions for achieving the described method. The method steps and / or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or order of operation is required for proper operation of the described methods, the order and / or use of specific steps and / or actions does not depart from the scope of the claims. It can be corrected.

  It should be noted that the term “couple”, “couple”, “coupled” as used herein and other usages of this word can indicate either indirect or direct connection. For example, if a first element is “coupled” to a second element, the first element can be indirectly connected to the second element, or can be directly connected. As used herein, the term “plurality” indicates two or more. For example, a plurality of elements indicates two or more elements.

  The term “determining” includes a variety of actions, thus calculating (calculating, computing), processing, deriving, investigating, referencing. (Lookup) (eg, refer to a table, database or another data structure), ascertaining, and the like. “Determining” may also include receiving (eg, receiving information) and accessing (eg, accessing data in a memory). Furthermore, “determining” may include resolving, selecting (selecting, choosing), establishing (establishing), and the like. The expression “based on” does not mean “based only on” unless expressly specified otherwise. In other words, the expression “based on” represents both “based only on” and “based at least on”.

  The above description of the disclosed implementations is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other implementations without departing from the spirit or scope of the invention. can do. Accordingly, the present invention is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

100 Assay Reader System 110 Barcode and Connectivity Module 112 Barcode Reader 114 Connectivity Marker 120 Barcode Module 122 Barcode Scanner 130 Base Assay Reader Device 132 Bay 134 Cartridge Receiving Opening 136 Display 138 Button 140 Cartridge 142 Barcode 144 Assay

Claims (20)

A diagnostic test device,
An optical sensor arranged to detect a change in the optical properties of the assay after applying a biological sample to the assay, and configured to generate a signal indicative of the detected change in the optical properties of the assay; ,
Module interface, and
The module interface is
A bay configured to receive a connection module of the plurality of replaceable modules and to engage and engage with the connection module;
A first signal path configured to identify a characteristic of the connection module indicating presence of a barcode scanner in the connection module and a connection capability of the connection module;
A second signal path configured to receive barcode data representing the barcode imaged by the connection module from the connection module;
Including
The diagnostic inspection apparatus comprises:
At least one processor;
A memory storing instructions,
With
The instructions include the at least one processor,
Determining an inspection result based at least in part on the signal generated by the optical sensor;
Identifying the barcode as an identification information barcode;
Determining identification information based on the barcode data;
Determining the connection capability of the connection module;
In response to determining that the connection module has a connection capability with a remote storage device, the test result is automatically transmitted to the remote storage device in association with the identification information;
In response to determining that the connection module does not have a connection capability with a remote storage device, the test result is automatically stored in the memory in association with the identification information.
Configure as
Diagnostic inspection apparatus characterized by that. And further comprising an additional optical sensor arranged to detect additional information on the assay or on a cartridge holding the assay, wherein the at least one processor uses the additional information to determine operating parameters of the diagnostic test apparatus. Configured to determine,
The diagnostic test apparatus according to claim 1. And further comprising an additional optical sensor arranged to detect additional information on the assay or on a cartridge holding the assay, wherein the at least one processor stores the additional information in association with the test result. Composed,
The diagnostic test apparatus according to claim 1. Further comprising the connection module;
The diagnostic test apparatus according to claim 1. The connection module includes the barcode scanner,
The diagnostic test apparatus according to claim 4. The connection module includes a cellular modem configured to provide the connection capability;
The diagnostic test apparatus according to claim 4. The connection module includes an information element, and the at least one processor retrieves module information from the information element via the first signal path and determines the connection capability of the connection module based on the module information. Configured to
The diagnostic test apparatus according to claim 4. A non-transitory computer-readable medium configured to have computer-executable instructions, wherein the computer-executable instructions are executed by a hardware processor at execution time.
Identifying the characteristics of the connection module inserted into the bay of the assay reader device indicating the presence of the barcode scanner in the connection module and the connection capability of the connection module;
Receiving from the assay read image sensor of the assay reader device assay image data representative of a detected optical property change of an assay inserted into or located adjacent to the assay reader device;
Determining test results based at least in part on analysis of the assay image data;
Determining a connection capability of the connection module based on the identified characteristics;
Automatically transmitting the test results to the remote storage device in response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device. When,
In response to determining that the connection module does not have a connection capability with a remote storage device, automatically storing the test results in the memory of the assay reader device;
A non-transitory computer-readable medium characterized by: At runtime, the hardware processor
Receiving barcode image data representing at least one barcode from the connection module;
Identifying the at least one barcode as an instruction barcode based on analysis of the barcode image data;
Retrieving an instruction associated with the instruction barcode;
Remembers more instructions to do
The non-transitory computer readable medium of claim 8. Further storing instructions that, when executed, cause the hardware processor to determine the test result based at least in part on the instructions;
The non-transitory computer readable medium of claim 9. Upon execution, the assay read image sensor is configured to acquire the assay image data at a predetermined timing after insertion of the assay into the assay reader device based at least in part on the instructions to the hardware processor. Remembers more instructions to be ordered,
The non-transitory computer readable medium of claim 9. At runtime, the hardware processor
Receiving barcode image data representing at least one barcode from the connection module;
Identifying the at least one barcode as an identification barcode based on analysis of the barcode image data;
Determining the information represented by the identification barcode;
In response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device, the information represented by the identification bar code together with the test result Automatically transmitting to the remote storage device;
In response to determining that the connection module does not have a connection capability with a remote storage device, the information represented by the identification barcode is automatically stored in the assay reader device memory together with the test result. Remembering,
Remembers more instructions to do
The non-transitory computer readable medium of claim 8. A diagnostic test method, wherein one or more hardware processors are
Identifying a characteristic of the connection module inserted into the bay of the assay reader device indicating the presence of a barcode scanner in the connection module and the connection capability of the connection module;
Receiving from the assay read image sensor of the assay reader device assay image data representative of a detected optical property change of an assay inserted into or located adjacent to the assay reader device;
Determining a test result based at least in part on an analysis of the assay image data;
Determining a connection capability of the connection module based on the identified characteristics;
Automatically transmitting the test results to the remote storage device in response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device. When,
Automatically storing the test results in a memory of the assay reader device in response to determining that the connection module does not have a connection capability with a remote storage device;
A diagnostic test method comprising: Receiving barcode image data representing at least one barcode from the connection module;
Identifying the at least one barcode as an instruction barcode based on an analysis of the barcode image data;
Retrieving instructions associated with the instruction barcode;
14. The method of claim 13, further comprising: Further comprising determining the test results based at least in part on the instructions;
The method according to claim 14. Further comprising: instructing the assay read image sensor to acquire the assay image data at a predetermined timing after inserting the assay into the assay reader device based at least in part on the instructions;
The method according to claim 14. Receiving barcode image data representing at least one barcode from the connection module;
Identifying the at least one barcode as an identification barcode based on analysis of the barcode image data;
Determining information represented by the identification barcode;
14. The method of claim 13, further comprising: In response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device, the information represented by the identification bar code together with the test result Automatically transmitting to the remote storage device;
In response to determining that the connection module does not have a connection capability with a remote storage device, the information represented by the identification barcode is automatically stored in the assay reader device memory together with the test result. Memorizing step;
The method of claim 17, further comprising: In response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device, the connection module is identified based on the information represented by the identification barcode. Further comprising automatically transmitting a command to transfer the test result from the remote storage device to another remote storage device;
The method of claim 17. In response to determining that the connection module has a connection capability with a remote storage device physically separated from the assay reader device, the connection module is identified based on the information represented by the identification barcode. Automatically sending the test results to a personal computer device of a clinician,
The method of claim 17.